MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3D; ABSORBABLE MESH

Model Number	100042-06
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Foreign Body Reaction (1868)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed infection, possible mesh rejection post implant of galaflex 3d mesh thereby underwent excision of mesh.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s reported postoperative course.Infection is clinically understood potential complications of surgery and is identified in the adverse reaction section of the instructions-for-use, supplied with the device as a possible complication.Regarding infection, the warnings section states, "if an infection develops, treat the infection aggressively.An unresolved infection may require the removal of the scaffold." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 608 units released for distribution in june 2023.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, on (b)(6) 2024 patient underwent a bilateral breast augmentation with galaflex 3d mesh implanted.It was reported that post implant, patient was presented with symptoms (fever and pocketing) of rejecting either the implants or the galaflex 3d thereby underwent removal of galaflex 3d mesh on (b)(6) 2024.As reported, the patient was prescribed antibiotics post op.
Additional Manufacturer Narrative
As reported, patient developed infection, possible mesh rejection post implant of galaflex 3d mesh thereby underwent excision of mesh.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s reported postoperative course.Infection is clinically understood potential complications of surgery and is identified in the adverse reaction section of the instructions-for-use, supplied with the device as a possible complication.Regarding infection, the warnings section states, "if an infection develops, treat the infection aggressively.An unresolved infection may require the removal of the scaffold." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2023.Addendum: h11: this supplemental mdr is submitted to correct the initial reporter occupation and manufacturing date.Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: e3 (initial reporter occupation) and h4 (device manufacture date).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, on (b)(6) 2024 patient underwent a bilateral breast augmentation with galaflex 3d mesh implanted.It was reported that post implant, patient was presented with symptoms (fever and pocketing) of rejecting either the implants or the galaflex 3d thereby underwent removal of galaflex 3d mesh on (b)(6) 2024.As reported, the patient was prescribed antibiotics post op.

• Brand Name: GALAFLEX 3D
• Common Device Name: ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 20640623
• Report Number: 1213643-2024-00536
• Device Sequence Number: 7471178
• Product Code: OOD
• UDI-Device Identifier: 00810054980315
• UDI-Public: (01)00810054980315(17)261123(10)LXHR0033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: LXHR0033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female